Single Use

The Maturation of Single-Use Applications

“Learn from yesterday, live for today, hope for tomorrow. The important thing is not to stop questioning.” —Albert Einstein     Single-use systems (SUSs) have been treated as novel technologies for some time. I have spent much of the past 10 years introducing clients to SUSs and integrating them into conventional processes. They are part of the biopharmaceutical development and production landscape and a mature, integrated option for bioprocessing. The value of SUS integration is soundly substantiated: reduced cross-contamination risk…

Single-Use Technology Supports Follow-On Biologics

    Follow-on biologics (FOBs, or biosimilars) differ from generic small-molecule compounds and pioneer biopharmaceuticals in several ways. Those differences affect aspects of their regulatory approval pathway, analytics, and marketing (1). Many biological active pharmaceutical ingredients (APIs) are actually incompletely characterized dynamic mixtures of macromolecules with slightly different primary compositions or higher-order structure (microheterogeneity). Those properties of macromolecules (unlike small molecules) are greatly influenced by their individual manufacturing process. Emerging regulatory guidelines for follow-on biologics are clarifying aspects of their…

Implementing Custom Single-Use Solutions for Cell Therapy Production

Cellular therapy continues to expand and gain momentum, as evidenced by the growing number of companies and clinical trials in the field each year. Early potential therapies were developed solely by investigators without communication or input from manufacturing experts. That communication gap led to numerous setbacks as potential products were developed without roadmaps for feasible manufacturing scale-up (or scale-out). Contributions from members of the cell therapy community over the past few years have significantly improved the situation in the form…

Reducing the Environmental Impact of Single-Use Systems

    Committed to sustainability, EMD Millipore is working to provide solutions for the life sciences industry. This commitment is driven by four global issues: climate protection, global health, clean water, and resource efficiency. The company is designing product and process improvements to address these challenges and meet customer expectations. Figure 1: ()   Life-cycle assessment (LCA) is one of the most rigorous tools we use to help us understand and quantify our products’ environmental impacts (Figure 1). This holistic,…

Sustainability in Bioprocessing

    The concept of sustainability has evolved over the past few decades to describe conditions for harmonious coexistence of industry and nature while meeting socioeconomic requirements of present and future generations. For this environmentally focused report, I like the simple definition offered by Armstrong International, a provider of steam, air, and hot water systems that improve utility performance, lower energy consumption, and reduce environmental emissions. According to a brochure that in part describes its work with Pfizer, Armstrong defines…

Monoclonal Antibody Manufacturing

    Continuing the theme of this occasional series, we examine the role of manufacturing in the supply chain in terms of what is required to deliver affordable medicines to patients. The industry has debated the relevance of manufacturing costs in the overall big picture (1). Rising manufacturing costs as a proportion of the overall selling price coupled with increased competitive pressures creates a strong drive to reduce manufacturing costs. However, cost of goods (CoG) is not the only strategic…

Mixing in Small-Scale Single-Use Systems

    Despite the advantages of presterile, single-use technologies, mixing is one of their most complex applications. Industry has been progressing toward using single-use bag technologies rather than traditional methods of stainless steel tanks and grades A/B processing because of the positive aspects they impart to end users, including a reduced potential for contaminants, cleaning, sterilization, and capital. These technologies offer simplicity and flexibility (1). However, using them for an operation such as mixing can add processing challenges. For example,…

Implementation of Single-Use Technology in Biopharmaceutical Manufacturing

    The increasing application of single-use components and systems in bioprocessing represents one of the most significant changes in biopharmaceutical manufacturing in recent times. Driven by various factors such as improved efficiency, flexibility, and economics, this trend also presents specific challenges to end users. In one industry review by Langer, extractables and leachable compounds from disposable components were considered by end users to be a major area of potential concern regarding safety, efficacy, and stability of the pharmaceutical product…

Polymers and Additives Used in Fabrication of Disposable Bioprocess Equipment

The materials used to fabricate single-use processing equipment for biopharmaceutical manufacturing are usually polymers, such as plastic or elastomers (rubber), rather than the traditional metal or glass. Polymers offer more versatility because they are light-weight, flexible, and much more durable than their traditional counterparts. Plastic and rubber are also disposable, so issues associated with cleaning and its validation can be avoided. Additives can also be incorporated into polymers to give them clarity rivaling that of glass or to add color…

Effect of Sterilization on the Mechanical Properties of Silicone Rubbers

    Silicone rubber is widely used in the pharmaceutical industry, where sterilizability is an essential requirement for all fluid transfer equipment. Pharmaceutical products are sterilized frequently and repeatedly by high-level energy and/or chemical vapor to eliminate bacterial surface contamination. Such treatments may also affect the molecular structure of silicone rubbers, causing changes in their physical properties and performance. Several studies on this topic have been reported; until now, however, no systematic investigation has been performed on the effect of…